Retrievable cardiac devices

ABSTRACT

Removable cardiac implants, applicators for inserting, repositioning and/or removing them, and methods of using them are described. In particular, removable or repositionable ventricular partitioning devices are described. Systems including removable implants and applicators for inserting and/or removing them are also described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 13/954,221, filed on Jul. 30, 2013, titled “RETRIEVABLE CARDIACDEVICES,” now U.S. Patent Application Publication No. 2013-0317537,which is a divisional of U.S. patent application Ser. No. 13/487,684,filed on Jun. 4, 2012, titled “RETRIEVABLE CARDIAC DEVICES,” now U.S.Pat. No. 8,500,790, which is a divisional of U.S. patent applicationSer. No. 12/198,022, filed on Aug. 25, 2008, titled “RETRIEVABLE CARDIACDEVICES,” now U.S. Pat. No. 8,246,671, each of which is incorporatedherein by reference in its entirety.

This application may be related to U.S. patent application Ser. No.10/436,959, filed on May 12, 2003, titled “SYSTEM FOR IMPROVING CARDIACFUNCTION,” which is a continuation-in-part of prior U.S. patentapplication Ser. No. 09/635,511, filed on Aug. 9, 2000, titled “DEVICEAND METHOD FOR TREATMENT OF HOLLOW ORGANS,” which claims priority fromU.S. Provisional Patent Application No. 60/147,894 filed on Aug. 9,1999, titled “EXPANDABLE, IMPLANTABLE DEVICE AND METHOD. Thisapplication is also a continuation-in-part of U.S. patent applicationSer. No. 11/151,164, filed on Jun. 10, 2005, titled “PERIPHERAL SEAL FORA VENTRICULAR PARTITIONING DEVICE.” Each of these patent applications isherein incorporated by reference in its entirety.

BACKGROUND OF THE DISCLOSURE

Described herein are systems, methods and devices for improving cardiacfunction, and may relate generally to the treating heart disease,particularly congestive heart failure, and more specifically, to asystems, methods, and devices for partitioning a patient's heartchamber.

Congestive heart failure annually leads to millions of hospital visitsinternationally. Congestive heart failure is the description given to amyriad of symptoms that can be the result of the heart's inability tomeet the body's demand for blood flow. In certain pathologicalconditions, the ventricles of the heart become ineffective in pumpingthe blood, causing a back-up of pressure in the vascular system behindthe ventricle.

The reduced effectiveness of the heart is usually due an enlargement ofthe heart. A myocardial ischemia may, for example, cause a portion of amyocardium of the heart to lose its ability to contract. Prolongedischaemia can lead to infarction of a portion of the myocardium (heartmuscle) wherein the heart muscle dies and becomes scar tissue. Once thistissue dies, it no longer functions as a muscle and cannot contribute tothe pumping action of the heart. When the heart tissue is no longerpumping effectively, that portion of the myocardium is said to behypokinetic, meaning that it is less contractile than the uncompromisedmyocardial tissue. As this situation worsens, the local area ofcompromised myocardium may in fact bulge out as the heart contracts,further decreasing the heart's ability to move blood forward. When localwall motion moves in this way, it is said to be dyskinetic, or akinetic.The dyskinetic portion of the myocardium may stretch and eventually forman aneurysmic bulge. Certain diseases may cause a global dilatedmyopathy, i.e., a general enlargement of the heart when this situationcontinues for an extended period of time.

As the heart begins to fail, distilling pressures increase, whichstretches the ventricular chamber prior to contraction and greatlyincreases the pressure in the heart. In response, the heart tissuereforms to accommodate the chronically increased filling pressures,further increasing the work that the now comprised myocardium mustperform.

Patients suffering from congestive heart failure are commonly groupedinto four classes, Classes I, II, III and IV. In the early stages,Classes I and II, drug therapy is presently the most common treatment.Drug therapy typically treats the symptoms of the disease and may slowthe progression of the disease, but it cannot cure the disease.Presently, the only permanent treatment for congestive heart disease isheart transplantation, but heart transplant procedures are very risky,extremely invasive and expensive and are performed on a small percentageof patients. Many patient's do not qualify for heart transplant forfailure to meet any one of a number of qualifying criteria, and,furthermore, there are not enough hearts available for transplant tomeet the needs of CHF patients who do qualify.

Substantial effort has been made to find alternative treatments forcongestive heart disease. For example, surgical procedures have beendeveloped to dissect and remove weakened portions of the ventricularwall in order to reduce heart volume. This procedure is highly invasive,risky and expensive and is commonly only done in conjunction with otherprocedures (such as heart valve replacement or coronary artery by-passgraft). Additionally, the surgical treatment is usually only offered toClass III and IV patients and, accordingly, is not an option for mostpatients facing ineffective drug treatment. Finally, if the procedurefails, emergency heart transplant is the only presently availableoption.

Mechanical assist devices have been developed as intermediate proceduresfor treating congestive heart disease. Such devices include leftventricular assist devices and total artificial hearts. A leftventricular assist device includes a mechanical pump for increasingblood flow from the left ventricle into the aorta. Total artificialheart devices, such as the Jarvik heart, are usually used only astemporary measures while a patient awaits a donor heart for transplant.

Other efforts to treat CHF include the use of an elastic support, suchas an artificial elastic sock, placed around the heart to preventfurther deleterious remodeling. Treatment of the heat by mechanicalmeans typically requires accurate and effective placement of treatmentdevices. Once a treatment device is implanted, it is often difficult (ifnot impossible) to correct or adjust placement of a treatment device.Furthermore, removal of a treatment device may require further invasiveprocedures. Thus, it would be beneficial to provide device, systems andmethods for removal of cardiac treatment devices that may address theseproblems.

Described herein are treatment devices that are configured to beremovable (or repositionable), systems for removing and/or repositioningsuch devices, and methods of removing and/or repositioning treatmentdevices.

SUMMARY OF THE INVENTION

Described herein are devices and systems including removable implants,applicators for inserting, repositioning and/or removing them, andmethods of removing them. The implants described herein are cardiacimplants that may be inserted into a chamber of a patient's heart,particularly the left ventricle. The implant may support the heart wall.In some variations the implant is a ventricular partitioning device forpartitioning the ventricle into productive and non-productive regions.

An implant typically includes a frame comprising a plurality of strutsformed of a relatively elastic and biocompatible material. For example,the frame may be formed of a metal or metal alloy. The frame may beformed of a shape memory alloy such as Nitinol. The implant may alsoinclude a membrane connected to the frame. The struts of the frame mayinclude a first end that is connected to a hub, and a second end thatincludes a passive anchor. A passive anchor may be configured to securethe strut to the wall of the heart. For example, the passive anchor maybe a sharp tip that is configured to partially penetrate the heart wall.The implant may also include a foot or anchor (including an activeanchor) at the distal end.

In general, an implant may be inserted into a heart chamber using anapplicator. An applicator typically includes a proximal end which mayinclude a handle and may also include one or more controls for operatingthe applicator. The applicator may also include an elongate bodyextending distally. The distal end of the applicator may be adapted forreleasably connecting to an implant. For example, the applicator mayinclude an implant stabilization shaft that can connect and release theimplant. The applicator may include one or more collapsing elements forcollapsing the implant. For example, the applicator may include a lariator collapse wire for collapsing the struts of the implant. In somevariations the applicator includes a collapse sleeve or umbrella/conefor collapsing an implant. In some variations the applicator includesone or more engagement elements for engaging a collapsing element on theimplant. For example, the applicator may include a capture wire, hook orthe like that may engage a strand or other collapse element (e.g.,collapse sleeve) on the implant that can assist in collapsing the strutsof the implant.

The implant may also be adapted for disengaging from the wall of theheart. For example, the implant may be shortenable or movable so thatany anchors on the implant, such as passive anchors on the struts or anactive anchor on distal end, can be disengaged prior to removing theimplant. In some variations the implant includes a shortenable region onthe stem and/or foot that can be shortened to separate the struts fromthe heart wall by shortening the length of the stem and/or foot region.Since the implant is typically concave relative to the heart wall,foreshortening the implant in this way may cause passive anchors at theends of the struts to withdraw from the wall of the heart. In somevariations the struts themselves are shortenable. For example, thepassive anchors may be retracted, allowing the implant to be removed.

In general, an implant may be removed and/or repositioned after it hasbeen implanted, as described herein. For example, an implant may bepositioned at a first location in a heart chamber such as within acardiac ventricle, the struts forming the implant may be expanded tosecure the implant in position. In some variations the implant maypartition the chamber (e.g., when a membrane spans the strut regions).In some variations, the implant is disengaged from the applicator priorto repositioning or removal; in other variations, the implant is notdisengaged from the applicator prior to repositioning or removal. Toremove the implant from the first location in the heart, the implant(e.g., the struts of the implant) is at least partially collapsed. Insome variations the implant may first be disengaged from the heart wall.The implant may be collapsed by activating a collapse element on theimplant, on the applicator, or both. For example, a strand connected tothe struts may be tensioned (e.g., by pulling) to collapse the struts.Thereafter, the implant may be drawn to the applicator. In somevariations the implant may be repositioned. In some variations, theimplant is withdrawn into a protecting element in the applicator, suchas a cannula or sleeve. After repositioning, the implant may be againdeployed. Alternatively, the implant may be removed from the patient bywithdrawing the implant and actuator from the patient.

For example, described herein is a method of deploying a ventricularpartitioning device comprising advancing a ventricular partitioningdevice having a membrane into a patient's left ventricle chamber in acontracted configuration, expanding the partitioning device into adeployed configuration at a first left ventricle location, at leastpartially collapsing the partitioning device into the contractedconfiguration, and withdrawing the partitioning device from the firstleft ventricle location. The method may also include the step ofrepositioning the partitioning device within the left ventricle andexpanding the portioning device into the deployed configuration at asecond left ventricle location so that the partitioning devicepartitions the left ventricle chamber into a main productive portion ofthe left ventricular chamber and a secondary, non-productive portion ofthe left ventricular chamber. In some variations, the method alsoincludes the step of removing the partitioning device from the patient.

The step of expanding the partitioning device may include expanding aframe connected to the membrane. The membrane may be a reinforcedmembrane.

The step of expanding the partitioning device may include allowing aframe connected to the reinforced membrane to self-expand. Also, asmentioned above, the step of withdrawing the partitioning device maycomprise pulling the device into a retrieval catheter.

In any of the variations described herein, the implant (e.g., theventricular partitioning device) may be secured or anchored to the firstleft ventricle location, and after repositioning, may be anchored to thesecond location.

The method may also include a step of disengaging the ventricularpartitioning device from the left ventricle in the first location. Forexample, any anchors on the implant may be collapsed, withdrawn, orotherwise removed. Thereafter, or simultaneously, the step of at leastpartially collapsing the partitioning device into the contractedposition may comprise pulling on at least one strand connected to thepartitioning device. In some variations, the step of at least partiallycollapsing the partitioning device into the contracted positioncomprises drawing a collapse sheath at least partially over thepartitioning device.

Also described herein are methods of deploying a ventricularpartitioning device including the steps of: advancing a ventricularpartitioning device having a membrane into a patient's left ventriclechamber in a contracted configuration, expanding the partitioning deviceinto a deployed configuration at a first left ventricle location,pulling on a strand in communication with the partitioning device to atleast partially collapse the partitioning device into the contractedconfiguration after it has been expanded, retrieving the partitioningdevice into a retrieval catheter; and withdrawing the partitioningdevice from the first left ventricle location.

The step of pulling on a strand in communication with the partitioningdevice may include pulling on an expansive strand extending from theperiphery of the reinforced membrane. The step of pulling on the standin communication with the partitioning device may include pulling on aretrieval wire at least partially surrounding the expanded reinforcedmembrane.

Also described herein are devices for partitioning a chamber of apatient's heart into a main functional portion and a secondarynon-functional portion. These devices (implants) may include: a membranehaving a collapsed configuration for delivery through a deliverycatheter and an expanded configuration for deployment within the heartchamber so as to partition the heart chamber into a main functionalportion and a secondary non-functional portion, an expandable frameformed of a plurality of struts having a distal end secured to a hub,wherein the membrane is secured to the expandable frame, a distallyextending stem, and a collapse element configured to convert thepartitioning component from the expanded configuration to the foldedconfiguration.

The collapse element may be a collapse sheath, a strand extending aroundthe periphery of the partitioning component and extending therefrom, orthe like.

Also described herein are devices for partitioning a chamber of apatient's heart into a main functional portion and a secondarynon-functional portion that include: a membrane having an expandedconfiguration and a collapsed configuration, wherein the membrane formsa recess when in the expanded configuration, an expandable frame formedof a plurality of struts having a distal end secured to a hub, whereinthe reinforced membrane is secured to the expandable frame, anon-traumatic distal tip, configured to engage a region of theventricular wall; and a strand extending at least partially around theperiphery of the membrane at or near the proximal end of the expandableframe, wherein the strand is configured to be tensioned to collapse thedevice from the expanded configuration to the collapsed configuration.

Also described herein is a system for partitioning a chamber of apatient's heart into a main functional portion and a secondarynon-functional portion, the system comprising an implant configured fordeployment into a heart chamber and an elongate applicator configured toinsert and retrieve the implant. For example, the implant may include aplurality of struts, wherein the struts are configured to have acollapsed delivery configuration and an expanded deployed configuration,and a strand extending between the struts, wherein the strand may betensioned to collapse the struts. The elongate applicator configured toinsert and retrieve the implant may include a control at the proximalend of the applicator for controlling release of the implant from theapplicator, and an elongate body extending from the proximal end to adistal end, wherein the distal end of the elongate body is configured torelaseably secure the implant. The strand extends proximally from theimplant along the elongate body of the applicator so that the strand maybe manipulated from the proximal end of the applicator.

The applicator may further comprise a port at the proximal end throughwhich the strand may pass. In some variations, the applicator includesan implant capture element at the distal end of the applicator. Theimplant capture element may be selected from the group consisting of: animplant capture sleeve and an implant capture umbrella.

Also described herein are methods of deploying, repositioning and/orremoving an implant comprising: advancing an implant into a patient'sleft ventricle chamber in a contracted configuration, wherein theimplant comprises a plurality of struts formed of a shape memorymaterial, expanding the implant into a deployed configuration at a firstleft ventricle location, changing the temperature of the implant to atleast partially collapse the implant into the contracted configuration,retrieving the implant into a retrieval catheter, and withdrawing theimplant from the first left ventricle location. In some variations, thestep of changing the temperature of the implant comprises exposing theimplant to cooled saline.

Also described herein are systems for partitioning a patient'sventricle, comprising: an implant configured for deployment into thepatient's ventricle, the implant including a plurality of struts,wherein the implant is configured to have a collapsed deliveryconfiguration and an expanded deployed configuration, and an applicatorconfigured to insert and retrieve the implant, comprising a control atthe proximal end of the applicator for controlling release of theimplant from the applicator, an elongate body extending from theproximal end to a distal end, wherein the distal end of the elongatebody is configured to releasably secure the implant, and a capture wireextendable from the applicator's distal end and configured to draw theimplant toward the applicator's distal end. The applicator may alsoinclude a control at the proximal end for manipulating the capture wire.

In some variations, the capture wire is configured as a lariat. In somevariations, the implant includes a strand that may be tensioned tocollapse the implant from the expanded configuration, and the capturewire of the implant is configured as a hook that may engage the strand.The capture wire may be connected to the implant.

In some variations, the applicator further comprises an inflatablesleeve configured to extend from the distal end of the applicator andcollapse the implant. As mentioned above, the applicator may include acapture umbrella configured to extend from the distal end of theapplicator and collapse the implant.

The implant may also include collapse sleeve configured to collapse thestruts. Thus, an applicator may include a collapse sleeve pullwireconfigured to engage the collapse sleeve on the implant.

Also described herein are systems for partitioning a patient'sventricle, the system comprising: an implant configured for deploymentinto the patient's ventricle and an elongate applicator configured toinsert and retrieve the implant. The implant may include a plurality ofstruts, wherein the implant is configured to have a collapsed deliveryconfiguration and an expanded deployed configuration, and a strandextending between the struts, wherein the strand may be tensioned tocollapse the struts. The elongate applicator configured to insert andretrieve the implant may include a control at the proximal end of theapplicator for controlling release of the implant from the applicator,an implant stabilization shaft extending distally from the proximal end,wherein the implant stabilization shaft is configured to releasablysecure to the implant, and a strand capture element extending distallyfrom the proximal end, wherein the strand capture element is configuredto engage the strand on the implant and collapse the struts of theimplant.

Also described herein are devices for partitioning a patient's ventricleinto a main functional portion and a secondary non-functional portionthat include: a membrane having an expanded configuration and acollapsed configuration, an expandable frame formed of a plurality ofstruts having a distal end secured to a hub, wherein the membrane issecured to the expandable frame, a stem extending distally from the hub,and a collapse sleeve configured to axially slide from the stem and tocollapse the expandable frame and membrane into a collapsedconfiguration. These devices may also include a passive anchor at theends of each of the struts of the expandable frame.

In some variations the devices include a non-traumatic foot at thedistal end of the device. The devices may also include an attachmentmechanism for a collapse sleeve pullwire.

Also described herein are removable or repositionable implants forpartitioning a chamber of a patient's heart into a main functionalportion and a secondary non-functional portion, comprising: a membrane,a plurality of struts secured to a hub at a first end, wherein themembrane is secured to the plurality of struts, and the plurality ofstruts and membrane have a collapsed delivery configuration and anexpanded deployed configuration for deployment within a heart chamber,wherein the membrane forms a recess when in the expanded configuration,wherein end of each of the plurality of struts includes a passive anchorconfigured to secure to the wall of the patient's heart, and a stemextending distally from the hub, wherein the stem comprises ashortenable region configured to be decreased in length and permit thepassive anchors to disengage from the wall of the patient's heart.

In some variations, the implant further includes a trigger configured toshorten the shortenable region of the stem. The trigger comprises a wireor line extending distally through the stem portion.

The shortenable region may be a collapsible region, or a telescopingregion. In some variations, the device includes a lock for locking theshortenable region.

Also described herein are methods of removing an implant that has beendeployed at a first ventricle location, wherein the implant includes aplurality of struts each having a passive anchor at a first end andconnected to a hub at a second end and a stem extending from the hub.The method may include the steps of: shortening a shortenable region ofthe stem to disengage the passive anchors from the heart wall, at leastpartially collapsing the plurality of struts, and withdrawing theimplant from the first left ventricle location.

In some variations, the step of shortening the shortenable regioncomprises applying pulling on a wire or string to shorten theshortenable region. The method may also include the step of unlockingthe implant so that the shortenable region may be shortened. The step ofat least partially collapsing the implant may include pulling on astrand or collapse line to draw the struts together.

The method may also include the step of repositioning the implant withinthe left ventricle and expanding the struts into a deployedconfiguration at a second left ventricle location. In addition, themethod may also include the step of removing the implant from thepatient.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one variation of a cardiac treatmentdevice including a hub, a frame, and a stem thereof.

FIG. 2A is a cross-section of a system including a cardiac device withthe cardiac device partially retracted into an applicator (e.g.,delivery catheter).

FIG. 2B is a cross-sectional side view of a portion of FIG. 2A.

FIG. 3A is a side view of the system of FIG. 2A with the cardiac devicefurther retracted.

FIG. 3B is a cross-sectional side view of a portion of FIG. 3A.

FIG. 4A is a side view of the system of FIG. 2A with the cardiac devicefully retracted.

FIG. 4B is a cross-sectional side view of a portion of FIG. 4A.

FIG. 5A is a cross-sectional side view of a human heart with a portionof an applicator inserted therein.

FIGS. 5B-5K are cross-sectional side views of the human heartillustrating installation (FIGS. 5B-5E), removal (FIGS. 5E-5H), andsubsequent final installation (FIGS. 5I-5K) of a cardiac device.

FIG. 6A is a perspective view of another variation of a cardiac device.

FIG. 6B is a cross-sectional side view of the human heart with thecardiac device of FIG. 6A installed.

FIG. 7A is a perspective view of another variation of a cardiac device.

FIG. 7B is a cross-sectional top plan view of the cardiac device on7B-7B′ in FIG. 7A.

FIG. 7C is a cross-sectional side view of the human heart with thecardiac device of FIG. 7A installed.

FIG. 8 is an elevational view of another variation of a partitioningdevice in an expanded configuration.

FIG. 9 is a plan view of the partitioning device shown in FIG. 8illustrating the upper surface of the device.

FIG. 10 is bottom view of the partitioning device shown in FIG. 8.

FIG. 11 is a perspective view of the non-traumatic tip of the distallyextending stem of the device shown in FIG. 8.

FIG. 12 is a partial cross-sectional view of the hub of the partitioningdevice shown in FIG. 9 taken along the lines 12-12′.

FIG. 13 is a transverse cross sectional view of the hub shown in FIG. 12taken along the lines 13-13′.

FIG. 14 is a longitudinal view, partially in section of a reinforcingstrut and membrane at the periphery of the partitioning device shown inFIG. 8.

FIG. 15 is a schematic elevational view, partially in section, of adelivery system with the partitioning device shown in FIGS. 8 and 9mounted thereon.

FIG. 16 is a transverse cross-sectional view of the delivery systemshown in FIG. 15 taken along the lines 16-16′.

FIG. 17 is an elevational view, partially in section, of the hub shownin FIG. 12 being secured to the helical coil of the delivery systemshown in FIG. 15.

FIGS. 18A-18E are schematic views of a patient's left ventricularchamber illustrating the deployment of the partitioning device shown inFIGS. 8 and 9 with the applicator shown in FIG. 15 to partition apatient's heart chamber (left ventricle) into a primary productiveportion and a secondary, non-productive portion.

FIG. 19 is a schematic plan view of the deployed device shown in FIG.18E within a patient's heart chamber.

FIG. 20A is a partial schematic view of the partitioning device shown inFIGS. 8 and 9 in a contracted configuration resulting from pulling thefree ends of the expansive strand at the periphery of the reinforcedmembrane.

FIG. 20B is a schematic view of the contracted device shown in FIG. 20Abeing pulled into an expanded distal end of an applicator to facilitatewithdrawal of the partitioning device.

FIG. 20C is a schematic view of the contracted device shown in FIG. 20Apulled further into the inner lumen of the receiving applicator.

FIG. 21 is a schematic view of another variation of an inserterconfigured to apply and remove and/or reposition an implant.

FIG. 22A-22F illustrate retrieval of a cardiac implant as (partitioningdevice) using the applicator of FIG. 21.

FIG. 23A illustrates another variation of an applicator.

FIG. 23B shows a cross-section through a region of the applicator ofFIG. 23A.

FIGS. 24A-24F illustrate a method of using the applicator similar tothat shown in FIG. 23A to retrieve an implant.

FIGS. 25A and 25B show another variation of a system including anapplicator and an implant in which the implant is secured to theapplicator and released from the applicator, respectively.

FIG. 26A shows another variation of an applicator configured to deliverand reposition and/or remove an implant, and FIGS. 26B-26D illustrateoperation of the applicator of FIG. 26A.

FIGS. 27A-27E illustrate the operation of a system including an implanthaving a collapse sleeve.

FIGS. 28A and 28B show front and side views, respectively, of an implanthaving a collapse sleeve, similar to the implant shown in FIGS. 27A-27E.

FIG. 29A shows an applicator including a retrieval element configured asa lariat. FIGS. 29B-29E illustrate operation of the applicator of FIG.29A and an implant.

FIGS. 30A and 30B show front and side views, respectively, of an implantthat may be used with the applicator shown in FIG. 29A and illustratedin FIGS. 29B-29E.

FIG. 31A shows another variation of a system including an applicator andan implant.

FIGS. 31B-31D illustrate retrieval of an implant using the system shownin FIG. 31A.

FIGS. 32A and 32B show another variation of an applicator configured forretrieval of an implant.

FIG. 33A and FIG. 33C-33H illustrate operation of an applicator similarto that shown in FIGS. 32A and 32B, and FIG. 33B shows a cross-sectionthrough a region of the applicator shown in FIGS. 33A and 33C-33H.

FIGS. 34A, 34C and 34E show an implant having a shortenable stem region.FIG. 34C shows the implant of FIG. 34A in which the stem region has beenshortened by tensioning an activating element. FIG. 34E shows theimplant of FIGS. 34A and 34C during removal of the activating element.FIGS. 34B, 34D and 34F show a slightly enlarged view of the stem regionsof the implants of FIGS. 34A, 34C and 34E, respectively.

FIGS. 35A-35E illustrate the operation of another system for deployingand removing an implant. The system includes an applicator (partiallyillustrated in FIGS. 35A-35E) and an implant.

FIG. 36A shows a cross-section of another variation of an implant, andFIGS. 36B-36C illustrate a method of removing an implant such as the oneshown in FIG. 36A, in which temperature is changed to induce collapse ofan implant so that it can be withdrawn.

DETAILED DESCRIPTION

Described herein are deployable and retrievable cardiac treatmentdevices or implants, systems including retrievable devices, and methodsof using them. For example, any of the implants described herein may bepositioned in a patient's heart (and particularly the patient'sventricle, such as the left ventricle), deployed into the heat byexpanding the device, and then, either immediately or after some timeperiod, disengaged from the heart, at least partially collapsed, andrepositioned and/or removed. The implants, which may also be referred toas cardiac treatment devices, may be configured to partition the heart(e.g., into a productive and non-productive region), or to support thewall of the heart. Examples of such implants are described herein.Applicators for deploying and/or retrieving any of the implantsdescribed herein are also taught, as are systems including theapplicators and the implants. Methods of using these implants are alsodescribed.

FIGS. 1, 6A, 7A and 8 show variations of implants (e.g., device 34 inFIG. 1). Any of the implants described herein may also be referred to ascardiac treatment devices or treatment devices. Alternatively, thesedevices may be referred to as ventricular partitioning devices orpartitioning devices. Such partitioning devices may be configured topartition a ventricle into function (or productive) and non-function (ornon-productive) regions. FIGS. 2A-2B, and 3 illustrate this implant(cardiac device 34) in more detail. The cardiac device 34 includes aframe 184 and a stem 186, or flexible body, and has a vertical axis 188.Partitioning devices, including ventricular partitioning devices, areonly one class of implants which are described herein and may be usedwith the device removal or repositioning systems and methods describedherein. Other such devices may be support devices that do not include amembrane, or do not partition a heart chamber, but predominantly supportthe cardiac tissue.

Referring now to FIG. 1, the frame 184 includes a frame hub 190, aplurality of main segments 192, and a membrane 194. The hub 190 in thisexample is a ring-shaped body with an outer surface with a diameter ofabout 5 mm, an inner surface with a diameter of about 4 mm, a thicknessof about 3 mm, and a pin extending off-center across the inner surfacecreating a smaller and a larger gap. The pin has a length of about 3.5mm and a diameter of about 1 mm and is located in a plane. The frame 184has a diameter 209 of approximately 75 mm, however, other embodimentsmay have diameters of between 10 mm and 120 mm. The entire hub 190 inthis example is made of nickel titanium.

In this example, the main segments 192 include first portions, orcentral segments, 210, second portions, or outer segments, 212, andpassive anchors 214. The first portions 210 are connected to the hub 190at a central portion of the outer surface and extend radially from thehub 190 at an angle away from the plane of the pin to a length of about8 mm. The second portions 212 of the segments 192 are connected to endsof the first portions 210 and further extend radially from the hub 190but at an angle towards the plane. The second portions 212 each have alength of 5-50 mm. The passive anchors 214 are formed at an end of eachof the second portions 212. The passive anchors 214 have sharp ends thatpoint slightly radially from the hub 190. The segments 192 are made fromnickel titanium, which after a prescribed thermal process, allows forthe segments 192 to hold their shape as illustrated in FIG. 1. Theentire frame 184, or just portions of the frame 184, may also be made ofstainless steel, polymers, or biodegradable material(s).

In FIG. 1, the membrane 194 is stretched over the first 210 and second212 portions of the segments 192 to give the frame 184 a disk likeshape. The membrane 194 is made of expanded Polytetrafuoroethylene(ePTFE) and has a thickness of about 0.08 mm. Other embodiments may usea mesh membrane, or other appropriate permeable, semi-permeable, orimpermeable membranes. While porous ePTFE material may be preferred, themembrane may be formed of suitable biocompatible polymeric materialwhich includes Nylon, PET (polyethylene terephthalate) and polyesterssuch as Hytrel. The membrane may be foraminous in nature to facilitatetissue ingrowth after deployment within the patient's heart. Theapplicator (including delivery catheter and/or a guiding catheter) maybe formed of suitable high strength polymeric material such as PEEK(polyetheretherketone), polycarbonate, PET, Nylon, and the like. Braidedcomposite shafts may also be employed.

The stem 186 may be made of Polytetrafuoroethylene (PTFE) and is thusexpandable and flexible. Referring again to FIG. 1, the stem 186 can becompressed or stretched by 30% of its length and can be bent from thevertical axis 188 of the device 34 by 90 degrees in any direction. Thefirst hub 232, second hub 234, and active anchor 236 may be made ofnickel titanium. In other embodiments, the hubs may be made of stainlesssteel.

FIG. 2A illustrates one variation of a systems including an applicator30 and an implant 34. The implant shown is the variation described abovefrom FIG. 1. The applicator shown in FIG. 2 includes a handle 44, adeployment member 46, which is partially within a catheter region(catheter tube 38). The proximal end of the deployment member 46 issecured to the handle 44. The handle may include one or more controlsfor deploying and/or retrieving an implant. For example, the handle maybe formed of molded plastic and may include knobs, buttons, or othercontrols for operating the applicator to deploy or retrieve a device.The distal end of a portion of the applicator (e.g., the deploymentmember 46) may be adapted to releasably grasp the implant.

In use, the deployment member 46 may be inserted through the cathetertube 38 so that the distal end 54 of the deployment member 46 may exitthe distal end of the tube 38. The deployment member 46 may connect to acardiac implant device 34 such that a key (not visible) engages the hub190 of the frame 184 of the implant by passing through the larger gap inthe hub 190. The implant may then be secured to the deployment member,and may be deployed by manipulation of a control on the handle, e.g., byrotating the key to disengage the implant from the deployment member.

As illustrated in FIGS. 2A and 2B, the distal end 54 of the deploymentmember 46 may be pulled into the distal end of the catheter tube 38. Asa proximal section of the frame 184 of the implant enters the cathetertube 38, it may be collapsed by the smaller diameter of the catheteropening of the applicator. For example, in the variation shown in FIG.2, the first portions 210 of the segments 192 begin to collapse towardsthe stem 186 when the implant is drawn into the catheter tube. Thesegments 192 collapse, or fold, against a spring force that is createdby the resilient nature of the nickel titanium material from which theyare made. At the same time, the second portions 212 fan out radiallyaway from the hub 190.

FIGS. 3A and 3B show a distal section of the frame 184 and the secondportions 212 of the segments 192 beginning to enter the tube 38, so thatthe second portions have been bent back to collapse towards the stem 186similarly to the first portions 210. FIGS. 4A and 4B illustrate thissystem 30 with the cardiac implant device 34 completely contained withinthe catheter tube 38.

FIGS. 5A-5J illustrate a human heart 242 while the implant 34 is beingdeployed. The heart 242 contains a right ventricle 244 and a leftventricle 246 with papillary muscles 248 and an akinetic (e.g., damaged)portion 250 with an apex 252. The distal end of the catheter 38 has beeninserted through the aorta and aortic valve into the left ventricle 246to a selected position where the ventricular partitioning device 34 canbe deployed. The catheter tube 38 is then partially pulled off of thecardiac device 34 exposing the stem 186.

The active anchor 236 is then deployed. In the implant shown in FIGS.1-5J, the implant includes an active anchor at the distal end. Thisanchor may be inserted into the tissue as illustrated in FIG. 5C. Inother variations (e.g., described below), the distal end of the implantmay be configured with one or more atraumatic feet that does notpenetrate the tissue. In FIG. 5C, the active anchor at the distal endmay be deployed into the tissue by operating (e.g., rotating) a control(e.g. an anchor knob) on the handle of the device. The active anchor 236penetrates the myocardium of the heart 242 to secure the cardiac device34 in the selected position at the apex 252 of the akinetic portion 250of the left ventricle 246.

The catheter 38 is then completely removed from the distal end 54 of thedeployment member 46, exposing the cardiac device 34. As the cardiacdevice 34 expands, due to the resilient nature of the segments 192, andthe pre-set shape of the frame 184, the passive anchors 214 on thesegments 192 penetrate the myocardium in a first direction. The membrane194 seals a portion of the ventricle 246 and separates the ventricle 246into two volumes.

If the cardiac device 34 has not been properly positioned, or if it isof the wrong size or shape for the particular heart, the device 34 maybe repositioned or completely removed from the heart 242, as illustratedin FIGS. 5E-5H.

For example, in variations in which an active anchor at the distal endhas been used, the implant may be removed by first releasing the activeanchor. If the implant has been completely deployed, e.g., so that theapplicator has been separated from the implant (which has been insertedinto the tissue), then the implant may re-coupled to the applicator. Forexample, the distal end of a portion of the applicator, such as thedeployment member 46, 54, may be connected to the implant. Thus, in FIG.5E, the applicator has been re-coupled to the deployment member 46 ofthe applicator. A control (e.g., knob, etc.) on the handle may bemanipulated to engage the applicator to the implant. In this variation acentral portion of the implant, such as the hub, is configured toreleasably engage and re-engage the applicator. In some variations anadditional tether or other element may be used to grab and position thedeployed implant so that it can be engaged with the applicator. Examplesand illustrations of these additional elements are provided in greaterdetail below.

Furthermore, the device may be repositioned before disengaging from theapplicator.

After the applicator has been engaged with the implant (or beforedisengaging the implant), activation of a control on the applicator(e.g., rotation of an anchor knob on the handle of the applicator) maydisengage the active anchor 236 from the left ventricle 246. The distalend 54 of the deployment member 46 may be retracted into the catheter 38to once again fold the cardiac device 34 into the position shown in FIG.4B, from where it can again be deployed. The passive anchors 214 may beremoved from the myocardium in a second direction which is approximately180 degrees from the first direction so that minimal damage is done tothe myocardium. This is illustrated in FIGS. 5F-5H.

The implant 34 may then be properly re-positioned, as shown in FIG. 5I,and deployed in the new location using the applicator. Once positioned,the applicator may be activated to release the deployment member 46 aspreviously described. After deploying it as desired, the distal end ofthe applicator may be separated from the cardiac device 34 to allowremoval of the deployment member 46 and removal of the applicator fromthe heart 242, as shown in FIG. 5J. FIG. 5K illustrates the heart 242with the cardiac device 34 installed and the deployment mechanism 36removed from the heart 242.

In this variation, the shape of the frame 184 allows the device 34 to beretrieved as long as the deployment member 46 is connected to the device34. When the device 34 is retrieved, the passive anchors 214 withdrawfrom the myocardium in a direction that is approximately 180 degreesfrom, or opposite, the first direction to minimize the amount of damagedone to the myocardium. The device 34 also provides support for theakinetic region 250, minimizes the bulging of the akinetic region 250,and reduces stress on the working parts of the myocardium. In general,the ePTFE membrane which may be used with the implants is biocompatible,has a non-thrombogenic surface, promotes healing, and acceleratesendothelization. These membranes may be used to partition the heart, aspreviously described.

FIG. 6A illustrates another variation of a cardiac device 254. Thecardiac device includes a hub 256, a frame 258, and a membrane 260. Thehub 256 lies at a central portion of the frame 258 and an active anchor262 is connected to the hub 256 and extends downwards therefrom. Theframe 258 includes a plurality of segments 264 which extend radially andupwardly from the hub 256. A sharp passive anchor 266 lies at the end ofeach of the segments 264. The membrane 260 is stretched between thesegments 264 to form a cone-shaped body.

FIG. 6B illustrates a sectional view of a human heart with the cardiacdevice 254 of FIG. 6A having been secured to an akinetic portionthereof.

FIG. 7A and FIG. 7B illustrate another variation of a cardiac device268. The cardiac device includes a hub 270, a frame 272, and membrane274. The hub 270 lies at a central portion of the frame 272 and anactive anchor 276 extends downwardly from the hub 270. The frame 272includes a plurality of segments 278 which extend radially and upwardlyfrom the hub 270. The segments 278 are of different lengths such that anouter edge 280 of the cardiac device 268 is not planar. The device 268has a vertical axis 282 which intersects a diameter 284 across the outeredge 280 of the device 268 at an angle other than 90 degrees. A sharppassive anchor 286 lies at the end of each of the segments 278. Themembrane 274 is stretched between the segments 278 to form a cone-shapedbody. Referring specifically to FIG. 7B, a cross-section perpendicularto the vertical axis 282 of the device 268 is circular.

FIG. 7C illustrates a sectional view of a human heart with the cardiacdevice 268 of FIG. 7A having been secured to an akinetic portionthereof. The outer edge 280 of the cardiac device 268 defines anon-planar cross-section of an inner surface of the left ventricle. Theimplant 268 can be sized and shaped for use on a wider variety of heartregions, including a variety of sizes and shapes of akinetic portions inleft ventricles.

In some variations, the implants may include one or more collapsingelements that are configured to help collapse the implant from theexpanded (deployed) configuration into the collapsed (or partiallycollapsed) position. For example, a sleeve or cover may be used tocollapse the frame of the implant. In other variations, the implant mayinclude a strand, wire, thread, cable, chain, etc. (which may generallybe referred to as a “strand”) for collapsing the device. For example, astrand may be included around the perimeter of the ribs or struts (e.g.,spaced from the central hub region by any desired spacing). The strandmay be a loop (e.g., joined at the ends) or it may have one or both endsfree. Pulling on the strand may contract the struts, drawing themtogether towards the collapsed configuration.

FIGS. 8-11 illustrate one variation of a cardiac implant deviceincluding a strand which may be used to collapse the device. In thisvariation, the implant (partitioning device) 10 includes a partitioningmembrane 511, a hub 512, preferably centrally located on thepartitioning device, and a radially expandable reinforcing frame 513that is secured to the proximal or pressure side of the frame 513 asshown in FIG. 8. The struts 514 have distal ends 515 which are securedto the hub 512 and free proximal ends 516 which are configured to curveor flare away from a center line axis. Radial expansion of the freeproximal ends 516 unfurls the membrane 511 secured to the frame 513 sothat the membrane presents a pressure receiving surface 517 whichdefines in part the productive portion of the patient's partitionedheart chamber. The peripheral edge 518 of the membrane 511 may beserrated as shown.

The variation shown in FIGS. 8-11 also includes a continuous expansivestrand 519 that extends around the periphery of the membrane 511 on thepressure side thereof. In operation, this strand may also help applypressure to the pressure side of the flexible material of the membraneto effectively seal the periphery of the membrane against the wall ofthe ventricular chamber. The ends 520 and 521 of the expansive strand519 are shown extending away from the partitioning device in FIGS. 8 and9. As mentioned, the ends 520 and 521 may be left unattached or may besecured together, e.g. by a suitable adhesive, knot, or the like, orsecured to the membrane 511 itself. While not shown in detail, themembrane 511 in this example has a proximal layer secured to theproximal faces of the struts 514 and a distal layer secured to thedistal faces of the struts in a manner described in U.S. patentapplication Ser. No. 10/913,608, filed on Aug. 5, 2004, hereinincorporated by reference in its entirety.

The hub 512 shown in FIGS. 10 and 11 may be connected to a non-traumaticsupport component 522. The support component 522 shown in FIGS. 10 and11 has a stem 523 a plurality of pods or feet 524 extending radiallyaway from the center line axis and the ends of the feet 524 are securedto struts 525 which extend between adjacent feet. A plane of material(not shown) may extend between adjacent feet 524 in a web-like fashionto provide further support in addition to or in lieu of the struts 525.The inner diameter of the stem 523 is threaded to secure thepartitioning device 510 to a delivery catheter as shown in FIGS. 15-17.

As shown in FIG. 12, the distal ends 515 of the struts 514 are securedwithin the hub 512 and, as shown in FIG. 13, a transversely disposedconnector bar 526 is secured within the hub which is configured tosecure the hub 512 to the nontraumatic support component 522.

In FIGS. 12 and 13, the screw thread inside stem 523 allows thepartitioning device 510 to be secured to the non-traumatic supportcomponent 522 and to be released from the delivery system within thepatient's heart chamber. The distal ends 515 of the reinforcing struts514 are secured within the hub 512 in a suitable manner or they may besecured to the surface defining the inner lumen or they may be disposedwithin channels or bores in the wall of the hub 512. The distal end ofthe struts 514 are preshaped so that when the struts are notconstrained, other than by the membrane 511 secured thereto (as shown inFIGS. 8 and 9), the free proximal ends 516 thereof expand to a desiredangular displacement away from the centerline axis which is about 20degrees to about 90 degrees, preferably about 30 degrees to about 60degrees. The unconstrained diameter of the partitioning device 510should be greater than the diameter of the heart chamber at the deployedlocation of the partitioning device so that an outward force is appliedto the wall of the heart chamber by the partially expanded struts 514during systole and diastole so that the resilient frame 513 augments theheart wall movement.

FIG. 14 illustrates the curved free proximal ends 516 of struts 514which are provided with sharp tip elements 527 configured to engage andpreferably penetrate into the wall of the heart chamber and hold thepartitioning device 510 in a deployed position within the patient'sheart chamber so as to partition the ventricular chamber into aproductive portion and a non-productive portion.

FIGS. 15-17 illustrate one variation of an applicator (delivery system)530 that may be used for delivering the partitioning device 510 shown inFIGS. 8 and 9 into a patient's heart chamber and deploying thepartitioning device to partition the heart chamber as shown in FIGS.18A-18E. The applicator system 530 includes a guide catheter 531 and adelivery catheter 532.

The guide catheter 531 has an inner lumen 533 extending between theproximal end 534 and distal end 535. A hemostatic valve (not shown) maybe provided at the proximal end 534 of the guide catheter 531 to sealabout the outer shaft 537 of the delivery catheter 532. A flush port 536on the proximal end 534 of guide catheter 531 is in fluid communicationwith the inner lumen 533.

The delivery catheter 532 in this variation includes an outer shaft 537with an adapter 538 on the proximal end thereof having a proximalinjection port 539 which is in fluid communication with the interior ofthe outer shaft 537. As shown in more detail in FIG. 16, the outer shaft537 has an inner shaft 541 which is disposed within the interior thereofand is secured to the inner surface of the outer shaft 537 by webs 543which extend along a substantial length of the inner shaft. Theinjection port 539 is in fluid communication with the passageways 542between the inner and outer shafts 541 and 537 respectively and definedin part by the webs 542. A torque shaft 544, which is preferably formedof hypotubing (e.g. formed of stainless steel or superelastic NiTi), isdisposed within the inner lumen 545 of the inner shaft 541 and has aproximal end 546 secured within the adapter 538. Balloon inflation port547 is in fluid communication with the inner lumen 548 of the torqueshaft 544. Torque shaft 544 is rotatably disposed within the inner lumen545 of the inner shaft 541 and is secured to rotating knob 549. Ahelical coil screw 550 is secured to the distal end 551 of the torqueshaft 544 and rotation of the torque knob 549 on the proximal end 546 ofthe torque shaft 544 rotates the screw 550 to facilitate deployment of apartitioning device 510. The proximal end 552 of inflatable balloon 553is sealingly secured by adhesive 554) about the torque shaft 544proximal to the distal end 551 of the torque shaft. The balloon 553 hasan interior 555 in fluid communication with the inner lumen 548 of thetorque shaft 544. Inflation fluid may be delivered to the ballooninterior 555 through port 547 which is in fluid communication with theinner lumen 548 of the torque shaft 544. The distal end 556 of theballoon 553 is sealingly secured by adhesive 557 to the helical screw550. The proximal and distal ends 552 and 556 of the balloon 553 areblocked by the adhesive masses 554 and 557 to prevent the loss ofinflation fluid delivered to the interior 555 of the balloon 553.Delivery of inflation fluid through a fluid discharge port 558 in thedistal end 551 of the torque shaft 544 inflates the balloon 553 which inturn applies pressure to the proximal surface of the partitioningcomponent 510 (or device) to facilitate securing the partitioningcomponent 510 to the wall 559 of heart chamber 560 as shown in FIGS.18A-18E discussed below.

As shown in FIG. 18A, the partitioning component 510 is deliveredthrough a delivery system 530 which includes a guide catheter 531 and adelivery catheter 532. The partitioning component 510 is collapsed in afirst, delivery configuration which has small enough transversedimensions to be slidably advanced through the inner lumen 533 of theguide catheter 531. Preferably, the guide catheter 531 has beenpreviously percutaneously introduced and advanced through the patient'svasculature, such as the femoral artery, in a conventional manner to thedesired heart chamber 560. The delivery catheter 532 with thepartitioning component 510 attached is advanced through the inner lumen533 of the guide catheter 531 until the partitioning component 510 isready for deployment from the distal end of the guide catheter 531 intothe patient's heart chamber 560 to be partitioned.

As shown in FIG. 18B-18C, the partitioning component 510 mounted on thescrew 550 is urged further out of the inner lumen 533 of the guidecatheter 532 until the support component 522 engages the heart wall 559.The guide catheter 531 is withdrawn while the delivery catheter 532 isheld in place until the proximal ends 516 of the struts 514 exit thedistal end 35 of the guide catheter. As shown in FIG. 18C, the freeproximal ends 516 of struts 514 expand outwardly to press the sharpproximal tips 527 of the struts 514 against and preferably into thetissue lining the heart wall 559.

With the partitioning component 510 deployed within the heart chamber560 and preferably partially secured therein, inflation fluid isintroduced through the inflation port 558 in the distal end 551 torqueshaft 544 where it is directed into the balloon interior 555 to inflatethe balloon 553. The inflated balloon 553 presses against the pressurereceiving surface 517 of the membrane 511 of the partitioning component510 to ensure that the sharp proximal tips 527 are pressed well into thetissue lining the heart wall 559 as shown in FIG. 18D.

With the partitioning device 510 properly positioned within the heartchamber 560, the knob 549 on the torque shaft 544 (as shown in FIG. 15)is rotated counter-clockwise to disengage the helical coil screw 550 ofthe delivery catheter 532 from the stem 523 secured within hub 512. Thecounter-clockwise rotation of the torque shaft 544 rotates the helicalcoil screw 550 which rides on the screw thread inside the stem 523secured within the hub 512. Once the helical coil screw 550 disengagesthe screw thread inside the stem 523, the delivery system 530, includingthe guide catheter 531 and the delivery catheter 532, may then beremoved from the patient.

The proximal end 534 of the guide catheter 531 is provided with a flushport 536 to inject fluids such as therapeutic, diagnostic or otherfluids through the inner lumen 533 during the procedure. Similarly, theproximal injection port 539 of adapter 538 is in communication withpassageways 542 if the delivery catheter 532 for essentially the samepurpose.

The deployment of the partitioning component 510 in the patient's heartchamber 560 as shown in FIG. 18E divides the chamber into a mainproductive or operational portion 561 and a secondary, essentiallynon-productive portion 562. The operational portion 561 is smaller thanthe original heart chamber 560 and provides for an improved ejectionfraction and an improvement in blood flow. Over time, the non-productiveportion 562 fills first with thrombus and subsequently with cellulargrowth. Bio-resorbable fillers such as polylactic acid, polyglycolicacid, polycaprolactone and copolymers and blends may be employed toinitially fill the non-productive portion 562. Fillers may be suitablysupplied in a suitable solvent such as dimethylsulfoxide (DMSO). Othermaterials which accelerate tissue growth or thrombus may be deployed inthe non-productive portion 562 as well as non-reactive fillers.

FIG. 19 is a top view of the deployed partitioning device shown in FIG.18E schematically illustrating the sealed periphery of the membrane 511against the ventricular wall.

Once the device is deployed, as shown in FIGS. 18E and 19, the devicemay be removed and/or repositioned. For example, in the implantvariation shown in FIGS. 8 and 9, pulling the strand 519 may disengagethe anchors or tip element 527 at the ends of the struts 514 from theheart wall. For example, the applicator 530 may be re-engaged with theimplant (e.g., the hub region). An element on the applicator may engagethe strand so that it can be pulled to collapse the implant. In somevariations, one or more ends of the strand remain connected to theapplicator during the insertion procedure, so that even when initiallydisengaged from the applicator, the strand is connected to theapplicator until the position is confirmed.

Examples of applicators including members for grasping and/ormanipulating a strand are described in greater detail below.

FIGS. 20A-20C illustrate the collapse and retrieval of an implant(partitioning device 510) by pulling on the ends 520 and 521 of anexpansive strand 519 which extends around the periphery of the membrane511. Typically, the partitioning device 510 may be secured to thedelivery catheter 532, but the delivery catheter is not shown in thisexample to simplify the drawings. In FIG. 20A the partitioning device510 is shown in a partially collapsed configuration. In FIG. 20B thepartially collapsed partitioning device 510 is shown being withdrawninto the flared distal end 563 of retrieval catheter 564. FIG. 20Cillustrates the completely collapsed partitioning device 510 pulledfurther into the retrieval catheter 564. The partitioning device 510 maybe withdrawn by pulling the device through the inner lumen 565 of theretrieval catheter 564. Optionally, the partitioning device 510 andapplicator (e.g., retrieval catheter) may be withdrawn from the patienttogether.

In this variation the applicator includes a flanged distal end on thecatheter, so that the implant may more readily be inserted into thedistal end of the applicator. This flanged distal end is optional, andis not necessarily present.

In general, the implantation, removal and/or repositioning of theimplants described herein may be performed under direct or indirectvisualization. For example, any of the procedures or methods describedherein may be performed under fluoroscopy. To assist in properlylocating the device during advancement and placement thereof into apatient's heart chamber, parts, e.g. the distal extremity, of one ormore of the struts 14 and/or the hub 12 may be provided with markers atdesirable locations that provide enhanced visualization by eye, byultrasound, by X-ray, or other imaging or visualization means.Radiopaque markers may be made with, for example, stainless steel,platinum, gold, iridium, tantalum, tungsten, silver, rhodium, nickel,bismuth, other radiopaque metals, alloys and oxides of these metals.

FIG. 21 shows another variation of an applicator configured to apply andretrieve and/or reposition a cardiac implant. In some variations, anapplicator such as the one illustrated in FIG. 21 is included as part ofa system including an implant. In FIG. 21, the applicator includes acontrol handle 701 having a plurality of controls for controllingengaging and disengaging from an implant, as well as a flush port 703and a balloon inflating port 705. In this variation, the applicator alsoincludes an elongate shaft 707 comprising an inner shaft 709 and anouter shaft 711. The distal end of the applicator includes an evertingballoon or inflatable sleeve 713 that is inflatable by applying fluid(e.g., air, liquid, etc.) through the inflation port 705. Inflating theeverting balloon may cause it to extend, as illustrated in FIGS.22A-22F. In addition to the features illustrated in FIG. 21, otherelements such as an implant stabilizing shaft and or a strand-graspinghook (not visible in FIG. 21) may also be included within the innershaft, and controlled proximally, e.g., using the handle. For example,the applicator may include a deployment member, as described above. Theimplant stabilizing shaft may be configured as a deployment member.

FIGS. 22A-22F illustrate operation of an applicator such as that shownin FIG. 21 to remove an implant (partitioning implant 720). FIG. 22Aillustrates a cardiac implant 720 that has been deployed into apatient's heart, as shown. The implant 720 includes a strand, suture 724that extends around the perimeter of the implant and has two ends 722,722′ which are knotted or otherwise prevented from pulling past themembrane surrounding the device. The strand 724 is threaded around theinner diameter of the implant.

In FIG. 22B, the applicator shown in FIG. 21 has been inserted into theheart so that the distal end of the applicator is positioned across fromthe deployed implant. The elongate catheter, including the inflatabledistal portion 713 is positioned across from the implant so that animplant stabilizing shaft 726 may be extended from the distal end of theapplicator to engage the implant. As previously described, the implantstabilizing shaft 726 (e.g., a deployment member) may engage with theimplant at the hub or any other appropriate region (e.g., the foot,etc.). A strand hook 728 may also be extended from the distal end of theapplicator as shown in FIG. 22B, so that it can extend from theapplicator and engage at least a portion of the strand. In somevariations, the strand hook is a grasper, jaw, or other strand-capturingelement. As shown in FIG. 22C, the strand can then be drawn proximallyby withdrawing the strand hook 728 proximally into the applicator whileholding the device in position. Drawing the strand proximally whilekeeping the device distally positioned will constrict the strand andcollapse the struts of the implant. In some variations, the method ofcollapsing the implant may include a step of pushing the implantdistally (away from the applicator) to disengage the ends of the strutsfrom the heart wall. As described in more detail below, the implant(e.g., the foot region) may also be configured to collapse or shorten tofacilitate disengaging of the struts from the heart wall.

After collapse of the implant, as shown in FIG. 22C, the applicator maybe extended over the implant. In one variation, illustrated in FIGS.22D-22E, the inflatable everting balloon or cuff 713 is inflated so thatit extends and advances over the implant. In some variations, the cuffon the distal end of the applicator is not inflatable, but is otherwiseextendable from the distal end to cover the device. For example, thedistal end may include a toroidal region that can be “rolled” over thecollapsed implant so that the implant is secured within the centrallumen of the toroidal region. Once the implant has been secured withinthe applicator, it may be removed, along with the applicator, from thepatient, or repositioned and deployed again.

FIG. 23A illustrates another variation of an applicator which may beused to apply and remove and/or reposition an implant. In FIG. 23A, theapplicator includes a handle region 801 having one or more controls. Inthe variation shown in FIG. 23A the handle includes a control, shown asa knob 803 for extending an capture umbrella (described below), and acontrol for operating a suture hook (suture hook knob 805). Theapplicator also includes an elongate catheter region 807, and suturecapture hook 822 as well as an implant capture umbrella 810.

FIG. 23B illustrates a cross-sectional view through the catheter regionof the applicator shown in FIG. 23A along line A-A′. As shown in FIG.23B, the applicator include an implant capture umbrella lumen 830 and asuture capture hook lumen 831. In some variations only a single lumen isused to house both the suture capture hook and the implant capturelumen. In some variations an implant stabilizing shaft is also included,similar to that described above in FIGS. 21 and 22A-F. For example, animplant stabilizing shaft (not shown in FIGS. 23A-24F) may be positionedconcentrically within the shaft connected to the implant captureumbrella. The implant stabilizing shaft may be operated independently ofthe implant capture umbrella 810.

FIGS. 24A-24F illustrate operation of an applicator as shown in FIG. 23Ato remove an implant that has been deployed in a patient's heart. FIG.24A shows an implant, similar to the implant shown and described forFIG. 22A, is shown implanted into the left ventricle 850 of a patient'sheart. The implant 720 also includes a suture or strand 724, having twoends that have been jointed together or knotted 722. The implant may beremoved from the deployed position in the heart as illustrated in FIGS.24B-24. The stand capture hook 822 is extended distally from theapplicator to capture or otherwise engage the strand 724 on the implant.In some variations an implant stabilization shaft 726 is also extendedfrom the distal end of the applicator so that it engages the implant, asshown for FIG. 22B, above. After capture of the strand, the standcapture hook 822 is drawn proximally back using the applicator. Forexample, the applicator handle may be manipulated to draw the strandproximally, e.g., by operating the strand hook knob 805. This results incollapsing the implant, as illustrated in FIG. 24C. Thereafter, theimplant capture umbrella 810 of the applicator is extended distally outof the catheter of the applicator. As shown in FIG. 24D, when theimplant capture umbrella is extended from the applicator, it expands asit leaves the implant catheter region. For example, the implant captureumbrella may be formed of struts of Nitinol or other materials that arebiased outwards. A membrane or netting may be present between thestruts. In some variations, the umbrella does not include a membrane,but comprises only struts. The struts may be coated (e.g., with apolymeric material) to prevent damage to the tissue and/or the implant.

The implant capture umbrella may be extended over the collapsed device720, as shown in FIG. 24D. The implant 720 may then be drawn into theapplicator by retracting the capture umbrella 810 (and an implantstabilization shaft, if included) into the catheter region of theapplicator, as shown in FIG. 24E. In some variations, the implant isonly partially withdrawn into the applicator. FIG. 24F illustratesremoval of the applicator and implant from the patient.

Although many of the applicator devices described herein are configuredfor both insertion and removal of an implant, it should be understoodthat an applicator can be configured as an implant removal device alone.For example, an implant removal device may otherwise resemble theapplicators described above (including FIG. 23A), but may not beconfigured to release the implant in the patient's heart after it hasbeen captured and removed. In some variations an implant removal deviceresembles the applicator of FIG. 23A, and does not include an implantstabilization shaft that is configured to release the implant.

In some variations, the applicator is configured so that the end or endsof the collapse or expansive strand extend proximally in the applicatorand can be removed (e.g., withdrawn) from the implant or the applicatorafter it has been finally positioned. For example, FIG. 25A illustratesone variation of a system including an applicator 901 and an implant903, in which the implant 903 includes a collapse strand 905 thatextends around the perimeter of the implant and can collapse the strutsof the implant if tensioned. The ends of the collapse strand 905 extendproximally into the applicator and extend from a port (e.g., on thehandle at the proximal end of the applicator) 906, 906′. The applicatorvariation shown also includes an implant stabilization shaft (catheter)909 which includes a balloon 907 for helping expand the implant oncepositioned, and an implant capture umbrella 920, within an outer cannulaor guide catheter 915 of the applicator, similar to the applicator shownin FIG. 23A. In this example, the distal region of the applicator alsoincludes a radiopaque marker 913 to aid in visualization. A ballooninflation port 927 is also present on the proximal end of the device.FIG. 25B illustrates the system of FIG. 25A in which the implant 903 hasbeen detached from the applicator 901. In FIG. 25B the collapse strand905 has been removed from the device. Presumably the device has beenpositioned in an acceptable position, and further adjustment isunnecessary. Until the strand is removed, the implant may becontinuously collapsed and repositioned by pulling on the collapsestrand 905, and using the implant capture umbrella 920 as previouslydescribed.

For example, FIGS. 26A-26D illustrate operation of the system of FIG.25A. FIG. 26A shows a perspective view of the system of FIG. 25A,including an implant 903 that is attached to the distal end of anapplicator 901. The very distal end of the implant includes a soft tipof foot 930. The implant may be inserted into the subject's heart (e.g.,the left ventricle) as previously described. Once in position, it may beexpanded as shown in FIG. 26A. The position or orientation of theimplant may be confirmed or checked using visualization such asfluoroscopy. FIGS. 26B-26D illustrate retrieval of the implant afterinitially deploying it, but before removal of the collapse strand 905.

The implant 903 shown in FIGS. 25A-26D may be retrieved by pulling thefree ends of the collapse wire 905 to collapse the implant, as shown inFIG. 26B. In this example, the passive anchors 935 can thus bedisengaged from the heart wall. After at least partially collapsing theimplant, the guide catheter 915 may be withdrawn to expose and expandthe implant capture umbrella 920, as shown in FIG. 26C. In somevariations, as described for FIG. 24C, above, the implant capture wiremay be extended distally. Drawing the implant proximally and thenpushing the guide catheter forward distally, as shown in FIG. 26D, willthen capture the implant within the implant capture umbrella as itcloses around the collapsed implant.

As mentioned briefly above, in some variations, the implant deviceincludes a collapse element, such as the collapse strand describedabove, or a collapse sleeve. FIGS. 27A-27E illustrate operation of asystem including an implant having a collapse sleeve and an applicatorconfigured to operate the collapse sleeve.

In FIG. 27A, the implant 1001 is shown in an expanded state. Forsimplicity sake, the struts are not shown. The implant includes acollapse sleeve 1005 that is positioned distally (e.g., over the stem ofthe implant) when the implant struts and membrane are deployed, as shownin FIG. 27A. In this example, the implant is coupled to an applicator1000, that includes a handle region having a collapse knob 1013, anactive anchor knob 1015, and a detachment knob 1010. The applicator alsoincludes a guide catheter 1007, within which an extendable/retractablecollapse sleeve pullwire 1006 and an implant stabilization shaft 1009reside. FIGS. 27B-27E illustrate use of the applicator to collapse theimplant 1005. For example, in FIG. 27B, the collapse knob (or otherappropriate control) on the handle may be operated to draw the collapsesleeve 1005 proximally. For example, turning the collapse knob may causethe pull wire to draw the collapse sleeve 1005 over the implantmembrane/struts, collapsing it, as illustrate in FIG. 27C. After theimplant is collapsed, it may be pulled inside the guide catheter andremoved from the patient, or repositioned and redeployed (e.g., byextending the implant from the guide catheter and pushing on thecollapse sleeve guidewire to expand the membrane/struts). The collapsesleeve pullwire may be a wire, a rod, a tube, etc., and may be used forpulling and/or pushing the collapse sleeve.

The collapse sleeve may be coupled with the collapse sleeve pullwire (orother collapse sleeve control on the applicator), using a configurationsuch as that illustrated in FIGS. 28A and 28B. FIG. 28A shows a frontview of an expanded implant including a centrally-located attachmentmechanism 1101 for the collapse sleeve. This attachment mechanism can bea cross-bar or wire that extends across the central opening and connectsto one or more points on the inner surface of the sleeve. In thisexample, both the hub region of the implant and the collapsiblestruts/membrane region include a track or slot along which thiscross-bar or wire can move to allow the collapse sleeve to be movedproximally or distally. For example, two opposite struts 1107 shown inFIG. 28A include a slot or track 1105 along which the cross-bar or wireconnected to the collapse sleeve may move. The applicator may include ashaft or wire that engages this attachment mechanism and pulls itproximally or pushes it distally. FIG. 28B shows a side view of theimplant shown in FIG. 28A, including the collapse sleeve 1110.

Another variation of an implant delivery system is shown in FIGS.29A-29E. FIG. 29A shows an applicator including a collapse line or lasso1201 extending from a side port on an implant stabilizing shaft passingthrough a guide catheter 1207 on the device. The distal end of theimplant stabilizing shaft includes a detachment screw 1205 that may beactivated to detach an implant from the device. In this example, thecollapse line may be drawn proximally (e.g., towards the handle of theapplicator 1211) by manipulating a control on the handle such as acollapse line control knob 1209. The handle may also include one or morecontrols for detaching the implant 1213, or the like. In some variationsthe collapse line is connected to an implant prior to deployment of theimplant, and may be released from the implant after it has been finallypositioned. In other variations, the collapse line is not integral tothe implant, but may be connected around the implant after it has beenreleased.

FIGS. 29B-29E illustrate operation of the implant delivery systemincluding the applicator and implant. For example, in FIG. 28B, thedeployed implant is still attached to the applicator, but it is desiredto collapse and reposition (or remove) the implant. In this variationthe implant includes an implant stem, configured as an atraumatic foot1220 extending from an expanded implant umbrella region 1222. In FIG.29C the collapse line or lasso 1201 is contracted to collapse theimplant until it is sufficiently collapsed to fit into the guidecatheter 1207, as shown in FIG. 29D. Once it has collapsed sufficiently,the guide catheter may be moved distally to enclose the implant, asshown in FIG. 29E. FIGS. 30A and 30B illustrate side and front views,respectively, of an implant which may be used with the applicator shownin FIG. 29A-29E. The implant is shown connected to a collapse line 1201(or strand) that passes through two or more skives 1250 on the membrane1240. The collapse line 1201 includes a push knot 1252. The implant alsoincludes multiple struts 1245.

FIGS. 35A-35E illustrate another variation of a system for applying andremoving a partitioning device (implant) that includes an applicatorhaving a collapse line. For example, FIG. 35A shows a system includingan applicator 1700 having a delivery cannula, and an implant 1701including expandable struts with passive anchors at their ends. Thesystem shown in FIG. 35A is in the undeployed state, and the distal endof the implant (including an atraumatic foot region extending distally).It can be deployed by pushing it from the delivery catheter region sothat the struts can expand, as shown in FIG. 35B. In this example, astrand or lariat 1705 is pre-positioned around the device, and passesinto a lariat guide tube 1707 that is within the delivery catheter. Asthe device is deployed, the lariat expands around it, and the lariatguide tube 1707 remains connected. If the position is correct, thelariat (string) may be withdrawn by pulling it from one end to remove itfrom around the device (not shown), and withdrawing both the lariat andthe lariat guide tube with the applicator 1700. FIGS. 35C-35E illustrateone method of repositioning or removing the implant by pulling on one orboth ends of the lariat and collapsing the implant (e.g., collapsing theexpanded struts, as shown in FIG. 35C), until it can be eitherrepositioned, as shown in FIG. 35D, or withdrawn into the deliverycatheter and removed, as shown in FIG. 35E.

In some variations the implant is retrieved into the applicator afterinverting the implant so that the membrane and/or struts may becollapsed as the implant is drawn into a catheter region of theapplicator. One variation of this method and a system including thismethod is shown in FIGS. 31A-31D. For example, in FIG. 31A, theapplicator includes a handle region 1401 having one or more controls1403, 1405, an elongate catheter region 1408 including a guide catheter,and an implant stabilization shaft and a retrieval line 1410 thatconnects to the distal end (e.g., the foot region 1422) of the implant.FIGS. 31B-31D illustrate removal of a deployed implant using thisapplicator. Pulling on the retrieval line 1410 after deployment willdisengage the implant 1420 from the walls of the left ventricle, asshown in FIG. 31C and invert the implant within the left ventricle (lv)as it is drawn towards the guide catheter in the applicator. In thisexample, the retrieval line 1410 is attached to a flexible foot region1422. Withdrawing the inverted implant into the applicator collapses theimplant, as shown in FIG. 31D.

FIGS. 32A and 32B illustrate another variation of an applicator 1500configured to remove an implant by inverting the implant, and FIGS.33A-33H illustrate the operation of the applicator 1500. In FIG. 32A,the system includes a handle region 1501 (control region) having aballoon inflation port 1503, an implant release port 1505, and animplant capture port 1507. The proximal control/handle region isconnected to an elongate insertion cannula. An implant stabilizationshaft 1509 configured to releasably secure to an implant and an implantcapture wire 1511 extend through the cannula, and are axially movabletherein. Thus, the cannula may include one or more internal axial lumenthrough which these structures may move. The implant stabilization shaftmay include a balloon 1515 or other deployment-aiding structure, and/ora screw 1513 that can be used to detach/reattach the implant. FIG. 33Bshows the device of claim 33A in partial cross-section, so that theimplant stabilization shaft 1509 and implant capture wire 1511 arevisible. The proximal end of the implant stabilization shaft 1509 isshown withdrawn so that the implant stabilization shaft is completelywithin the cannula.

FIGS. 33A-33H illustrate operation of this system. In FIG. 33A, theapplicator 1500 of FIGS. 32A and 32B is shown in partial cross-sectionwith an implant 1520 pre-loaded on the distal end. The implant capturewire 1511 in this variation is pre-loaded through the implant, so thatit extend from the implant release port, through the implant, and out ofthe implant capture port. For convenience, FIG. 33A shows the implant inan expanded (deployed) configuration, although it may also be contractedin a delivery configuration in which the struts and any membrane betweenthem is collapsed and retracted at least partially into the deliverycatheter.

FIG. 33B shows a cross-section through the distal region of the implant,showing a passageway through which the implant capture wire may pass.This passageway may be sized so that a retainer 1530 on the end of theimplant capture wire cannot pass through the implant, so that it can beretrieved by pulling on the wire, as illustrated below. If the implantit positioned and deployed as desired, the implant capture wire may becompletely withdrawn through the implant. For example, the retainer 1530on the end of the implant capture wire may be removed or disengaged.

After deploying the device into a heart, e.g., into the left ventricleof the heart, the device may be withdrawn. For example, to remove theimplant from the heart, one end of the implant capture wire 1511 may bewithdrawn down the device, as illustrated in FIG. 33C. In this example,the implant capture wire is drawn proximally by pulling on the end ofthe implant capture wire extending from the implant capture port 1507.The opposite end of the implant capture wire is attached to a retainer1530. The retainer is sized (or otherwise configured) so that it cannotpass through the implant hub 1533, as shown in FIG. 33D.

FIG. 33E shows the implant stabilization shaft disengaged from theimplant 1520. With the implant stabilization shaft attached, the implantmay partially withdrawn from the wall of the heart, to allow it space tomove (e.g., within the ventricle) so that it has adequate room to beflipped, as illustrated in FIG. 33F. For example, pulling on the implantcapture wire 1511 extending from the implant capture port 1507 will drawthe foot (tip) of the implant to be drawn towards the applicator (thedistal end of the cannula). In the example shown in FIG. 33F, the distalend of the catheter is marked with a radiopaque marker 1550, so that theposition of the applicator can be observed. FIGS. 33G and 33H illustratethe steps of collapsing the implant into, by continuing to secure theimplant at the distal end of the applicator (e.g., pulling on theimplant capture wire 1511) while sliding a guide catheter, sheath, orcollapsing catheter 1539 over the flipped implant. The guide catheter(or sheath, or collapsing catheter) 1539 moves axially over the deliverycatheter 1561 to extend distally beyond the end of the guide catheter,and the distal end of the both may include a radiopaque marker 1550.Once collapsed, the implant and applicator may be removed from thepatient.

In any of the variations described herein the implant may be removedafter it has been at least partially secured or even anchored to thepatient's heart wall. For example, an implant may include passiveanchors at the ends of the ribs (struts), which may be pointed or sharp,and configured to partially penetrate the heart wall. Removal orre-positioning of the implant may therefore be simplified by disengagingthe implant from the heart wall. In some variations a portion of theimplant is axially shortenable (e.g., collapsible, compressible, etc.)after it has been deployed so that it can be disengaged. For example,the hub and/or foot region of the implant may be collapsible, asillustrated in FIGS. 34A-34D. In some variations the shortenable regionis a telescoping region. In some variations the shortenable regionincludes a spring or other biasing element that holds the region is anextended (unshortened) position until it is allowed to compress orotherwise activated. Thus, the shortenable region may be activated byapplying force to shorten it. In some variations, the shortenable regionis lockable so that it cannot be shortened until the lock is disengaged.A lock may include a pin, a catch, or the like. The lock may bemechanically, electrically or magnetically activated.

FIG. 34A shows an implant having an elongated hub region 1601 thatincludes a collapse region 1601. The hub region 1601 of FIG. 34A isshown in more detail in FIG. 34B. In this variation, the collapsibleregion includes hinged arms. The hub region in this example may beforeshortened by pulling proximally on a string (or strings) 1605attached distally to the collapse region 1601. This is illustrated inFIG. 34C, and in greater detail in FIG. 34D. In this example, the stringpasses from the proximal end of the implant (and may pass through orinto an applicator), loops around a hole in the implant, and then backout proximally. After the device position is finalized, the string 1605may be removed by withdrawing one end of the string while allowing theother end to be pulled through the implant and out again, as illustratedin FIGS. 34E and 34F.

In other variations, the foreshortening of the implant does not requirea string, but may be activated by merely applying pressure or force tothe device.

In addition to the devices and methods for collapsing an implantdescribed above, other methods may also be applied, either separately orin combination with the methods described above. For example, theimplant may be collapsed by changing the temperature of the implant.This method is particularly effective when the implant is made (at leastpartially) of a shape memory material, such as Nitinol. FIG. 36A shows across-section through one variation of an implant 3600 in which thedevice includes a frame (e.g., having struts 3601), and a centrally (andproximally) located tip 3603 that may be grasped by an applicator, asillustrated in FIGS. 36B and 36C, described below. The frame (e.g.,struts 3601) may be formed in part from a shape-memory material that maytransition between an expanded (Austentite) configuration into acollapsed (Martensite) configuration when exposed to cold.

FIGS. 36B and 36C illustrate this transition. In FIG. 36B the device3600 has been inserted in to left ventricle 3612. An applicator 3609including a pair of grabbing jaws 3615 (although any coupling means forsecuring the implant to the applicator may be used, including thosedescribed above) is brought near the implant, and the jaws 3615 may besecured to the tip 3603 of the implant. The applicator also includes achannel for applying chilled fluid 3621. For example, cooled saline(e.g., between 0 and 10 degrees C.) may be applied from the channel 3621to change the Nitinol of the implant from the austenite phase (expanded)to the martensite phase (collapsed). This is illustrated in FIG. 36C.The implant 3600 is shown in a collapsed configuration, disengaged fromthe wall. The implant is also shown being drawn into the applicator(which may include a catheter into which the implant may be withdrawn.In this example, the central region of the applicator, including thegrasping jaws 3615 can be withdrawn into the outer cannula of theapplicator.

To the extent not otherwise described herein, the various components ofthe implants, applicators, and delivery systems including any of themmay be formed of conventional materials and in a conventional manner aswill be appreciated by those skilled in the art.

While particular forms of the invention have been illustrated anddescribed herein, it will be apparent that various modifications andimprovements can be made to the invention. Moreover, individual featuresof embodiments of the invention may be shown in some drawings and not inothers, but those skilled in the art will recognize that individualfeatures of one embodiment of the invention can be combined with any orall the features of another embodiment. Accordingly, it is not intendedthat the invention be limited to the specific embodiments illustrated.It is intended that this invention to be defined by the scope of theappended claims as broadly as the prior art will permit.

What is claimed is:
 1. A method for removing or repositioning an implantin a heart chamber, the implant including a plurality of self-expandingstruts and a strand extending transversely across the struts, the methodcomprising: providing an applicator comprising an elongate body having aproximal end, a distal end, and a strand capture element extendable fromthe distal end; inserting the distal end of the applicator into theheart chamber; extending the strand capture element from the distal endof the applicator; engaging the strand with the strand capture element;tensioning the strand with the strand capture element to collapse theself-expanding struts of the implant; and withdrawing at least a portionof the collapsed self-expanding struts of the implant into the distalend of the applicator.
 2. The method of claim 1, wherein the applicatorfurther comprises an implant stabilizing shaft extendable from thedistal end of the applicator.
 3. The method of claim 2, furthercomprising: extending the implant stabilizing shaft from the distal endof the applicator; and engaging the implant with the implant stabilizingshaft.
 4. The method of claim 1, wherein the applicator furthercomprises a control at the proximal end of the elongate body that isconfigured to manipulate the strand capture element.
 5. The method ofclaim 1, wherein the strand capture element is a hook.
 6. The method ofclaim 1, wherein the strand capture element is a grasper.
 7. The methodof claim 1, wherein the strand capture element is a jaw.
 8. The methodof claim 1, wherein the strand is tensioned with the strand captureelement by withdrawing the strand capture element proximally into theapplicator.
 9. The method of claim 1, further comprising pushing theimplant distally to disengage the implant from a wall of the heartchamber.
 10. The method of claim 1, wherein the applicator furthercomprises an implant capture umbrella extendable from the distal end ofthe applicator.
 11. The method of claim 10, further comprising extendingthe implant capture element distally out of the applicator and over atleast a portion of the collapsed self-expanding struts of the implant.12. The method of claim 1, wherein the applicator further comprises aninflatable everting cuff located on the distal end of the applicator.13. The method of claim 12, further comprising inflating the inflatableeverting cuff until the inflatable everting cuff extends over at least aportion of the collapsed self-expanding struts of the implant.
 14. Amethod for removing or repositioning an implant in a heart chamber, theimplant including a plurality of self-expanding struts and a strandextending transversely across the struts, the method comprising:inserting an applicator into the heart chamber, the applicatorcomprising an elongate body having a proximal end, a distal end, a lumenextending therethrough, an implant capture umbrella extendable from thedistal end of the applicator, and at least one end of the strand of theimplant extending proximally into the lumen of the applicator; pullingthe at least one end of the strand to collapse the self-expanding strutsof the implant; extending the implant capture element distally out ofthe applicator and over at least a portion of the collapsedself-expanding struts of the implant; and withdrawing at least a portionof the collapsed self-expanding struts of the implant into the distalend of the applicator.
 15. The method of claim 14, wherein theapplicator further comprises an implant stabilizing shaft extendablefrom the distal end of the applicator.
 16. The method of claim 15,further comprising: extending the implant stabilizing shaft from thedistal end of the applicator; and engaging the implant with the implantstabilizing shaft.
 17. The method of claim 14, wherein the applicatorfurther comprises an inflatable everting cuff located on the distal endof the applicator.
 18. The method of claim 17, further comprisinginflating the inflatable everting cuff until the inflatable evertingcuff extends over at least a portion of the collapsed self-expandingstruts of the implant.
 19. A method for removing or repositioning animplant in a heart chamber, the implant including a plurality ofself-expanding struts and a strand extending transversely across thestruts, the method comprising: providing an applicator comprising anelongate body having a proximal end, a distal end, and a strand captureelement extendable from the distal end; inserting the distal end of theapplicator into the heart chamber; extending the strand capture elementfrom the distal end of the applicator; engaging the strand with thestrand capture element; and tensioning the strand with the strandcapture element to collapse the self-expanding struts of the implant.20. The method of claim 19, further comprising repositioning theimplant.
 21. The method of claim 20, further comprising releasing thestrand from the strand capture element to expand the self-expandingstruts of the implant.